On Aug. 23, the U.S. Food and Drug Administration granted full approval to the Pfizer COVID-19 vaccine for people 16 and older. With full approval, the Pfizer vaccine will now be called “Comirnaty.” Public health departments across Western Wisconsin hope that this approval will increase vaccine confidence across the region. While full approval was granted for people 16 and older, children age 12-15 can still receive the vaccine under the Emergency Use Authorization.
The announcement of the FDA’s full approval of the Pfizer COVID-19 vaccine came on the same day that Gov. Tony Evers announced that Wisconsin residents who get the vaccine can receive a $100 Visa Gift Card. Any Wisconsin resident who receives their first dose of vaccine from a provider located in Wisconsin from Aug. 20 through Sept. 6 can receive a gift card.
“This formal approval is another step in showing that these vaccines are safe and effective,” said Barron County Health Officer Laura Sauve. “With the announcement of the governor’s new reward program, it is a great time for someone who was on the fence to call their doctor, pharmacist or local health department for an appointment.”
What is the difference between Emergency Authorization and Full Approval?
Emergency Use Authorization (EAU): This is used during a public health emergency. To receive EUA, the product’s known potential benefits must be proven to outweigh the known potential risks. The product must go through three trial phases, have its data reviewed, and receive approval by FDA, ACIP, CDC, and WI DHS before the vaccine can be given. COVID-19 vaccines currently under EUA in the United States include:
- Moderna for those 18 and older
- Johnson & Johnson/Janssen for those 18 and older
- Pfizer for those 12 through 15
Full approval: Approved when substantial evidence of safety and evidence has been provided. COVID-19 Vaccines under Full approval in the United States include:
- Comirnaty (Pfizer) for those 16 and older
- The FDA has required that COVID-19 vaccines under EUA follow similar processes as fully approved.
- Pfizer’s vaccine contains messenger RNA (mRNA). The mRNA gives the body instructions to create antibodies that will be able to fight the COVID-19 virus if infected with it in the future. This causes the body to make a protein similar to the protein in the virus that causes COVID-19. Then the immune system can defend the body if exposed to the virus. The mRNA is only in the body for a short time. It does not become part of, or change, the body’s own genetic material or DNA.
- Cases continue to rise in Wisconsin and in the Northwestern region. It is important that people continue to be vaccinated and follow COVID-19 precautions. Vaccination is an important tool in returning our lives to normal, rebuilding our economy and reducing the likelihood of hospitalization and death.
To find a vaccine, visit vaccines.gov or call 211.